The National Institute for Clinical Excellence has issued its guidance on the use of the combination therapy interferon alpha and ribavirin for the treatment of hepatitis C. This is the 14th technology guidance issued by the Institute to the NHS in England and Wales.
The guidance recommends that NHS specialists should use a combination of interferon alpha and ribavirin to treat the majority of people over the age of 18 years with moderate to severe hepatitis C, and states which tests should be used to confirm the diagnosis of hepatitis C.
Andrew Dillon, the Institute's Chief Executive said, "hepatitis C is a potentially life threatening disease and the use of these drugs in combination to treat it varies considerably across the NHS in England and Wales. I am confident that both the NHS and people with hepatitis C will welcome the clarity this guidance brings".
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Contact:
Anne-Toni Rodgers 020 7766 9170
Lucy Betterton 020 7766 9161
Notes for editors
General Information
1. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 12pm (lunchtime) on Tuesday 31st October.
2. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
3. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. That is we use a team of experts to produce guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes around 12 months to complete and involves the manufacturers of the technology, patient groups and professional organisations.
4. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
5. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, NICE will produce audit tools for use in the clinical setting.
6. The full Guidance and patient notes are also available from:
Tel: 0541 555 455 Post: PO Box 777 London SE1 6XH
Fax: 01623 724 524 Email: doh@prologistics.co.uk
Information on Hepatitis C and Interferon Alpha and Ribavirin
7. Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. Six major types of the hepatitis C virus have been found, these are genetic types (genotypes) and at least 4 out of 10 people who suffer from hepatitis C are infected with genotype 1.
8. The virus is generally transmitted parenterally (by any means except digestion). Patients often get the virus through intravenous drug use and the sharing of needles. The virus was also spread through blood transfusion prior to the introduction of screening in 1991, as well as through blood products before the viral inactivation programme in the mid-1980s. There is a small risk of infection from tattooing, electrolysis, ear piercing and acupuncture. Infection through sexual intercourse can also occur and if a mother has the virus then there is a 6 in 100 chance she will pass it to her child. HIV infection is thought to increase the risk of transmission.
9. People exposed to the virus, often do not have symptoms, however about 2 in 10 will quickly develop acute hepatitis, and may feel weak and uncomfortable and loose their appetite, symptoms that have been described as flu-like with jaundice. 85 out of 100 people exposed to the virus go on to develop chronic hepatitis C.
10. Development of the disease is slow and variable and can happen over 20-50 years. Of those infected 2 to 3 out of 10 people develop advanced liver disease (cirrhosis) within 20 years and a small number of these get cancer of the liver (hepatocellular carcinoma). People with end stage liver disease or cancer of the liver develop severe symptoms and may require a liver transplant. A third of all people infected may never progress to cirrhosis or will not progress for at least 50 years
11. Interferon alpha can be used alone to treat people with the Hepatitis C virus. This is called monotherapy and the precise way it works is not known. Around 47 out of 100 people with the virus respond to this treatment, but in more than half of those who respond the infection returns within six months of stopping treatment. This treatment is given by an injection under the skin three times per week. Injections may be given by clinical staff or by the patient after training. Patients who respond to this treatment usually do so within three to four months, but some have had to continue with treatment for 12 months.
12. Ribavirin is a tablet that is currently licensed for use in combination with interferon alpha for the treatment of certain people with the hepatitis C virus.
13. Results from clinical trials (involving 1744 individual patients) show that 67 out of 100 patients infected with hepatitis C virus (not genotype 1) respond to combination treatment within 24 weeks, this response is sustained and there is no gain from a further 24 weeks of treatment.
14. Adverse effects related to combination therapy include influenza-like symptoms (fatigue, headache, fever), anaemia, , gastrointestinal complaints (loss of appetite, nausea), dermatological symptoms (alopecia), psychiatric disturbances (depression, anxiety) and hypo- or hyperthyroidism.
15. The total budget impact for the NHS of combination therapy depends on a number of factors: prevalence, proportion of patients diagnosed, proportion of these who attend for assessment, and proportion considered suitable for treatment. It is estimated that there will be about 7,000 patients in England and Wales treated in the first instance. Assuming that treatment of these patients is spread out over three years, that all receive 6 months' treatment and two-thirds receive 12 months' treatment, the drug cost would amount to about £55 million, or about £18 million per year.
16. As knowledge of the disease and its treatment becomes more widespread, it is also likely that more people than otherwise will be diagnosed and will seek treatment. It is estimated that the annual continuing drug cost would be about £5 million. However, it is most likely that rates of diagnosis, referral to specialists, biopsy and acceptance of the therapy will all increase, so this estimate of annual costs after three years is likely to be an underestimate.
17. This guidance will be reviewed in October 2003.
